Conference Day One - Wednesday September 10, 2025
8:00 am Check In, Coffee & Light Breakfast
8:45 am Chair’s Opening Remarks
Establishing the State of Play for PAT & Emerging Trends in the Pharma & Biopharma Industry
9:00 am Panel Discussion: Exploring the Major Advancements & Challenges of PAT in Drug Development & Manufacturing to Enhance Collaboration & Innovation
Synopsis
- Highlighting emerging trends and technologies for real-time process control
- Identifying the industry-wide obstacles professionals working with PAT are facing in 2025
- Proposing approaches to tackle technical, data management and business challenges
9:30 am Quantitative Cellular PAT Analytics Driving Improvements in Advanced Therapy Process & Production Outcomes
Synopsis
- Label-free analysis of intrinsic biochemical and biophysical properties of cells provides real-time insights into cellular changes occurring throughout a manufacturing process
- Learn how Laser Force Cytology™, a label-free, quantitative precision PAT enables real-time monitoring of CQAs and CPPs delivers insights into complex manufacturing processes through its optical force univariate and multivariate machine learning predictive capabilities
10:00 am Speed Networking
Synopsis
A prime chance to make the most of in-person networking and forge new connections designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussion during the summit.
10:40 am Morning Break & Refreshments
Exploring Technologies & Techniques to Advance Real-Time Pharma
11:40 am Enabling Faster, More Reliable Drug Production: Implementing PAT for Real-Time Release in API/DP Manufacturing
Synopsis
- Insights from years of hands-on experience implementing PAT in DP manufacturing
- Challenges and practical solutions for integrating online measurements into real-time process control for API and DP
- Real-world applications of PAT for enabling real-time release testing: what’s working and what still needs work
12:10 pm Empowering 5.0 BioSolutions Through Real-Time Process Analytical Technology & Computational Controls, Increasing Efficiency & Quality
Synopsis
- Outlining the importance of digital infrastructure to not only manage large volumes of data but utilize these in decision-making
- To identify the gaps in expertise that hinder the effective use of advanced data analytics in CM and propose strategies to close these gaps
- Exploring how organizations can move towards continuous manufacturing without inhouse chemometric expertise
12:40 pm Lunch & Networking Break
Understanding Data Analytics to Enable Real-Time Quality Monitoring of Drugs & Biologics
2:10 pm Leveraging Advanced Data Trending in Continuous Manufacturing to Accelerate Timelines
Synopsis
- Overview of a trending program developed to monitor and optimize continuous manufacturing (CM) processes
- Challenges and opportunities of working with high-volume, high-frequency data in CM environments
2:40 pm Leveraging PAT in Collaboration with Model-Based Controls to Achieve Automation & Streamline Processes
Synopsis
- Integration of PAT tools with control models: Demonstrate how PAT data can feed directly into model-based control strategies (e.g: MPC) for real-time decision making and enhanced process understanding
- Closed-loop automation for consistency and efficiency: Illustrate the benefits of automated feedback control systems driven by PAT measurements, enabling tighter control of critical quality attributes and reducing variability
- Scalable frameworks for continuous improvement: Highlight how combining PAT with digital twins or first-principles models supports process optimization, scalability, and compliance with Quality by Design (QbD) principles
3:10 pm Afternoon Break & Refreshments
The Business Cases: Demonstrating the Value of PAT
3:40 pm Case Study: Request for Implementation of PAT Tools & Data Trending to Enhance Process Monitoring
Synopsis
- Considering project lab development history and value added from PAT during campaigns execution and data monitoring
- Following the tech transfer timeline from PAT request to its introduction in manufacturing towards daily process monitoring
- Improvement of traditional batch sampling through PAT and effective discussion during process data monitoring
4:10 pm Case Study: Demonstrating Value of Introducing IPC Testing to Accelerate Production & Release Time of Drug Products
Synopsis
- Success story of smaller-scale PAT tool implementation, where value was demonstrated with small in-process control introductions
- Learning how companies considering implementation of PAT can justify the business case through small steps
- Uncovering the return on investment that was seen by moving away from batch testing to gain support from key stakeholders
4:40 pm Panel Discussion: Navigating Resistance to Innovation in Pharma & Strategies to Secure Stakeholder Buy-In for New Technologies
Synopsis
- Sharing of knowledge on challenges encountered with key decision makers in implementing PAT
- Crowd-source solutions to align stakeholders and gain buy-in for prioritising PAT in both development and manufacturing